drugset / Trial / NCT01126086

Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment

NCT01126086

Phase 1 Completed 25 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: \- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban. Secondary Objective: \- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.

Timeline

Start
2010-05
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Otamixaban Small molecule 100 ug/kg Intravenous

Indications

No indication recorded.